Africa’s first HIV cure trial was built around the deliberate inclusion of women in clinical trials – and the initial results are promising. Scientists are moving closer to discovering a made-in-Africa cure for HIV, thanks to a group of young women volunteers.
A study on the first HIV “cure trial” in Africa, conducted in the port city of Durban, shows four out of 20 women with acute HIV infection remained off antiretroviral therapy (ART) for approximately 18 months. The four young women maintained undetectable viral loads and normal CD4 counts during this time.
The trial, conducted at the Females Rising through Education, Support and Health (FRESH) clinical research site, sought to eliminate or reduce hidden traces of HIV in the body so the immune system could keep the virus in check without the need for antiretroviral therapy.
The trials focused mainly on young women aged between 23 and 30 years. Researchers said the focus on women was deliberate since women account for the largest share of people living with HIV but are often less represented in cure trials.
“It is therefore very important that women are included in cure trials because interventions may work differently in women versus men. Our study hopefully opens the door for more HIV cure clinical trials in populations that need it most,” said Thumbi Ndung’u, Director for the Sub-Saharan African Network for TB/HIV Research Excellence (SANTHE).
According to Ndung’u, globally, 53% of people living with HIV are women. However, women account for only 17% of participants in HIV cure trials conducted so far.
In Africa, women represent 57% of individuals living with HIV, indicating that they are disproportionately affected by the epidemic. Data from UN Women shows that every week, 4,000 young women and girls worldwide are newly infected with HIV, with 3,100 of those cases occurring in sub-Saharan Africa.
A Clinical Director at the FRESH research site and an Infectious Disease Specialist Physician, Dr. Krista Dong, also expressed her concerns about the underrepresentation of women in HIV-related research, saying it is time to shift our focus toward interventions specifically designed for women on the continent.
“When we come with an intervention that’s going to be highly effective, we need to know it’s going to work in women, not only from a scientific and physiologic standpoint, but have we created something that women want and are willing to use,” said Dr. Krista.
To be eligible for the trial, participants had to be “virally suppressed” on ART for at least 12 months. The woman from FRESH had been on ART and virally suppressed for a median of 6.9 years.
Having started ART very early made this group of women unique, in that HIV had little time to replicate before they started treatment.
“What this means is that their viral reservoir was smaller and less diverse which may have made it easier for this intervention to achieve viral control,” said Dr. Krista.
Among the four women who were able to control the virus after the combination of three drugs cleared their systems, the median duration off ART was 1.5 years, with one individual having been off ART for as long as 2.4 years.
While these results show significant ‘promise’ for a potential cure for HIV, there is still a long way to go before drug production can begin on the continent.
Dr. Krista said that a drug that’s successful in four people or 20% is not yet significant enough for a drug company to take it forward, develop it for distribution, or even conduct a large phase three trial where thousands of people are enrolled.
“We were encouraged that it did have a signal and shows that this approach of using a combination immunotherapy can be successful. But right now, it was not universally successful to take this forward,” She said.
The scientists are leveraging the insights to find out what’s happening in the bodies of the four women that’s different from the bodies of the other 16 women. Their outcomes will inform future therapies that will be critical when developing something else, making this more broadly applicable.
A separate study, Socio-Behavioral Research (SBR), was conducted to assess the perceptions and experiences of trial participants and the views of community members, clinical staff, and family members of selected trial participants.
“Most of the participants said they will participate again because even a little thing like getting a break from taking their medication was a great opportunity for them,” said SBR Investigator, Ntombifuthi Langa.
However, the researchers said stigma is still very heavy in the setting, and the majority of the women did not disclose their participation in the research to their partners.
“That’s very, very significant because this particular kind of research, you interrupt your ARVs. And when you do that, there’s the risk that the virus then rebounds, or comes back in the blood, and you can transmit that to your partner. So that’s a concern,” explained Dr. Dong.
Participants were provided with pre-exposure prophylaxis (PrEP)- medicine usually given to HIV negative people- to protect their partners from potential infection in case they experience a rebound while on treatment.
“Majority of the partners interviewed were so happy about this trial because taking medication daily is really depressing and would releive their partners from daily medication,” said SBR Investigator, Ayanda Zulu.
The researchers said this work is critical to informing the development of new interventions and the conduct of research.
“It’s critical conducting cutting-edge science like this, particularly when it’s first time in Africa, that we get our communication and our messaging back and accurate, and that we consider the local setting, language and culture,” said Dr. Krista.
The researchers will present the results to community members and study participants in early April to inform them of their role in the science and how it’s moved the field of HIV. They plan to do the Knowledge awareness exercise each year from then on.
Credit: Conrad Onyango, Bird Story Agency
